As of this week, the following products manufactured from expanded cord blood have been granted expedited pathways to FDA approval.
Parent's Guide to Cord Blood Foundation published a review of expanded cord blood products in May 2018.
Date | Expanded Cord Blood Product | Manufacturer | Indication | FDA Expedited Path(s) |
20180717 | NiCord® | Gamida Cell | HSCT: Hematopoietic Stem Cell Transplants | Breakthrough Therapy Orphan Drug |
20180806 | NLA101 Dilanubicel | Nohla Therapeutics | HSCT engraftment, Neutropenia | Orphan Drug Fast Track |
20180823 | Pneumostem® | Medipost | Bronchopulmonary Dysplasia | Orphan Drug Fast Track |
20190423 | ECT-001 | ExCellThera | Hematologic Malignancies | Regenerative Medicine Advanced Therapy (RMAT) |
20190904 | MGTA-456 | Magenta Therapeutics | Inherited Metabolic Disorders | Regenerative Medicine Advanced Therapy (RMAT) |
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